Physicians utilize catheters in many procedures to gain access to interior remote regions of the body. It is a paramount factor that the physician has total control utilizing precise movements of the catheter when inside the body. Many of the invasive procedures within the body include entry into the heart especially when an ablation therapy is utilized. Thus, total and precise control over the tip of the catheter is required. In addition, it is preferable to have the physician control both the catheter as well as any device for treatment or observing when utilized within the body.
Numerous innovations for steerable catheters have been provided in the prior art that are described as follows. Even though these innovations may be suitable for the specific individual purposes to which they address, they differ from the present invention as hereinafter contrasted.
In U.S. Pat. No. 5,456,664, titled Catheter Steering Mechanism for pulling a first catheter steering wire while simultaneously allowing a second catheter steering wire to remain static, and vice versa. The mechanism includes at least one rotatable gear and means, such as a rotatable knob, for manually rotating the gear. A first linearly slidable toothed rack is attached to the proximal end of one steering wire, and a second linearly slidable toothed rack is attached to the proximal end of the other steering wire. A toothed gear rotatable by rotation of the knob engages each of the toothed racks to move them linearly in opposite directions in response to rotation of said gear. Preferably three intermeshing gears are used so that movement of the racks are in the same direction as the rotation of the knob. Preferably the steering wires are connected to the racks by connection that transfer tension as the racks move away from the wires but allow the wires to remain static, when the rack moves toward its associated wire.
In U.S. Pat. No. 5,454,794, titled Steerable Light Diffusing Catheter, invented by Hugh L. Narcisco, Jr. and Steven C. Anderson, titled Steerable Light Diffusing Catheter, a steerable catheter is disclosed which can treat luminal surfaces such as those occurring in the vascular tree, pulmonary tree, gastrointestinal tract, urological organs, etc. with Photodynamic Therapy (PDT) or other optical diffusing treatments. The catheter, which may include an inflatable balloon portion, has a light diffusing tip which can be deflected allowing the catheter to be steered precisely. The light diffusing tip on the steerable catheter is able to gain access to and enter virtually any sub-branch of the luminal system being treated. Since this catheter does not require a guidewire lumen for insertion, the profile is reduced. A low profile device allows treatment light to be delivered to the walls of the most distal, small diameter lumen.
In U.S. Pat. No. 5,437,636, titled Steerable Catheter with Fiberoptic Scope Inserting Means, invented by Phillip J. Snoke, David S. Rowley, David G. Lincoln and Kirk W. Charles, a catheter for use in body vessels or cavities has a housing of such size as to be readily held in the hand of a user and elongate tube means having one end connected to the housing and extending outwardly therefrom and being formed of material of such a stiffness so as to maintain the elongate tube means in straight condition in the absence of an external force applied thereto, where an outer end portion of the elongate tube means is flexible. Guide wires are connected to the housing by the inner ends thereof and extend outwardly therefrom through the elongate tube means. The outer ends of the guide wires are connected to the flexible outer end portion of the elongate tube means. Guide wire control means is carried by the housing and cooperates with the inner end portion of the guide wires for controlling the angular attitude of the flexible outer end portion of the elongate tube means.
In U.S. Pat. No. 5,396,880, titled Endoscope for Direct Visualization of the Spine and Epidural Space, invented by Jonathan Kagan, Roger White and David L. Brumfield, a system for direct visualization of the spine and the epidural and/or intra-discal space to facilitate diagnosis and treatment of spinal conditions is disclosure, which is adapted for percutaneous introduction into the spinal space. The system includes a disposable flexible catheter, a fiberoptic bundle disposed within the catheter which is connected to a light source and camera. The bundle is removably and adjustably connected to the proximal end of the catheter to permit rotation of the bundle relative to the catheter. A mechanism for controllably deflecting the tip of the catheter is provided to vary the viewing angle of the fiber-optic bundle within and to assist in steering the catheter through the spinal space. The mechanism includes a deflection wire extending through the catheter and affixed at the distal end thereof. The proximal end of the deflection wire is affixed to a sleeve which is slidably disposed around the catheter and within a housing. The housing includes an internal flange that defines a stop surface which is contacted by the sleeve as the catheter and deflection wire is moved in a first direction. After the sleeve contacts the stop surface, further movement of the catheter in the first direction causes tension in the wire between the sleeve and the wire's securement to the catheter, thereby bending the catheter tip in the direction of the securement. The catheter can be rotated with the tip in its deflected position to provide a conical viewing region within the spinal space.
The above described patented inventions differ from the present invention because they lack one or more of the following features described and claimed in the present invention: manifold strain relief, steering dial, lumen extrusion shaft having an upper lumen extrusion shaft large lumen opening and a lower lumen extrusion shaft large lumen opening and a pair of lumen extrusion shaft small lumen openings, lumen extrusion tip, fastening means, luer lock, steering wire, catheter body lumen tubing, steering wire guide, manifold, and/or hemostatis valve/touhy borst side port.
Numerous innovations for steerable catheters have been provided in the prior art that are adapted to be used. Even though these innovations may be suitable for the specific individual purposes to which they address, they would not be suitable for the purposes of the present invention as heretofore described.